This job is currently Archived,
Regulatory Affairs Specialist - Luxembourg
Flen Pharma (company)
Posted on : 19 April 2017
- Our company is an international, innovative wound care group with companies.
- In a few years’ time, it gained a leading position in the Belgian wound care market, its Home market and is working towards reaching this on an international level.
- This result is due to a twofold reason:
- dedicated people
- products combining innovation with significant progress in wound care, inspired by our motto: We help you live the life you love.
- We are looking for a full time Regulatory Affairs Specialist, for immediate start at our headquarter.
- As a Regulatory Affairs Specialist, you will be responsible for the regulatory affairs processes in countries defined by the Head of Regulatory Affairs and more specifically be in charge of the following tasks in the defined countries:
Tasks and responsibilities:
- You are responsible for product registration submissions of company’s products, renewal approvals, product technical dossiers and other regulatory documents
- You are responsible for the regulatory compliance of company’s clinical studies, in close collaboration with clinical department
- You are responsible for the regulatory compliance of communication activities and material regarding company's products, in close collaboration with marketing and sales
- You keep abreast of international legislation, guidelines and customer practices by keeping in contact with official institutions
- You identify evolving regulatory trends including international trends that are relevant and ensure that appropriate action is initiated
- You serve as regulatory contact person for company with distributors and authorities
- You monitor the administrative management of translations of the distributed material
- You perform a regulatory check of all communicated information e.g. packaging material (brochures, packaging, information for users…)
- You will have to work in close collaboration with and report to the Head of Regulatory Affairs
- Scientific (ideally university) degree
- At least 2 years’ experience in international medical devices regulatory affairs; knowledge of regulatory affairs related to FDA and other non-EU regulations is an asset
- Project management knowledge is an asset
- Familiar with MS Office and database applications
- Fluency in English is a must, fluency in Dutch is a great asset, fluency in German and/or French is an asset
- Proficient in written and oral communication
- Analytical ability
- Planning & organizing
- Quality minded
- Autonomous worker
- Team player
- Diplomatic and open minded
Work with us:
- Our company is a young and growing, independent Organisation with short communication lines, and where entrepreneurship is appreciated.
- Its products are innovative, patented and are well regarded by the key opinion leaders internationally.